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Antibiotic
Antibiotics for Cat Bite Injuries (CATBITE Trial)
Phase 4
Recruiting
Led By Kevin M Klifto, DO, PharmD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2; day 7+/-2; day 14+/-2; day 30+/-2
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial investigates duration of prophylactic antibiotics & placebo control for cat bites to the hand/forearm to reduce incidence of infection.
Who is the study for?
Adults over 18 who've been bitten by a cat on the hand or forearm within the last 24 hours can join this trial. They must speak English and be willing to take medication and attend follow-ups. Excluded are those with active infections, recent antibiotic use, immunodeficiencies, certain chronic diseases, fever above 100.4°F, pregnancy, malnutrition or hypersensitivity to study drugs.
What is being tested?
The CATBITE trial is testing if antibiotics prevent infection after a cat bite to the hand/forearm. Participants will randomly receive either a placebo; amoxicillin-clavulanate for one day; or amoxicillin-clavulanate for five days. The study will monitor infection development and assess disability and quality of life through questionnaires.
What are the potential side effects?
Possible side effects from antibiotics may include digestive issues like diarrhea or nausea, allergic reactions such as rashes or itching, and rarely more serious effects like severe intestinal conditions (C.difficile) or anaphylaxis in case of allergy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 2; day 7+/-2; day 14+/-2; day 30+/-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2; day 7+/-2; day 14+/-2; day 30+/-2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes of the incidence of infection
Incidence of infection
Secondary study objectives
Adverse effects
Changes in HAND Questionnaire (HAND-Q) scores
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
+3 moreOther study objectives
Changes in location of cat bites that result in infection
Location of cat bites that result in infection
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Antibiotic x 1 dayActive Control5 Interventions
Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 1 day (4 days of placebo capsules)
-Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 1 day
Group II: Antibiotic x 5 daysActive Control4 Interventions
Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 5 days (0 days of placebo capsules)
-Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 5 days
Group III: Placebo (microcrystalline cellulose)Placebo Group2 Interventions
Placebo capsules by mouth twice daily x 5 days (5 days of placebo microcrystalline cellulose capsules)
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
381 Previous Clinical Trials
628,740 Total Patients Enrolled
1 Trials studying Hand Injuries
6 Patients Enrolled for Hand Injuries
Kevin M Klifto, DO, PharmDPrincipal InvestigatorUniversity of Missouri-Columbia